Human Research Protection Office (HRPO)

Vincent - Great Changes on the Horizon!

George Cerminara, University of Pittsburgh Finance

Join George Cerminara in this discussion about Vincent.  As a joint venture between the University of Pittsburgh and UPMC, Vincent was developed as the next generation of our WePay software. Vincent expands the functionality of WePay and streamlines the design around you, the user, to make the experience much simpler and more efficient.  This session will talk about Vincent and include a demo of the system.

Exempt Submissions 101

Dana DiVirgilio, Research Review Analyst

The purpose of this session is to provide an overview of the federal criteria for “exempt” submissions.  It is often difficult to determine whether your project meets one of the exempt categories.  By attending, you will learn the basics of exemptions and be able to apply this knowledge to determine the appropriate exempt application form for your project.  The following topics will be discussed:

Single IRB of Record

Michelle LeMenager, Reliance Specialist, Human Research Protection Office

The National Institute of Health (NIH) issued a federal policy that requires certain types of NIH-funded studies to use a single IRB (sIRB). The goal of this policy is to streamline the IRB review process and it goes in effect on January 25, 2018. Topics to be discussed will include:

Consent Language Does Affect Your Ability to Share Data/Specimens

Jean Barone, Director, Human Research Protection Office
Melissa Miklos, Associate Director, Human Research Protection Office

Learn about the Do’s and Don’ts when creating your consent document. Words do matter and too often restrictive wording and promises to destroy the data/specimen are included in the consent. This presentation will be discuss best practices and address the following topics:

NIH Clinical Trials Requirements, FORMS-E, the Common Rule, and Single IRB: What You Need to Know

The Human Research Protection Office, Research Conduct and Compliance Office, Clinical & Translational Science Institute, and the Office of Research will be presenting “NIH Clinical Trials Requirements, FORMS-E, the Common Rule, and Single IRB: What You Need to Know”.  Representatives from each office will discuss what changes have already been implemented, which ones are coming, and the resources available to faculty and administrators to help navigate them. As noted below, the program will be repeated on November 28th.

Overview of the New Common Rule

Revisions have been made to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects (The Common Rule, 45 CFR 46).  The final rule is scheduled to be effective on January 19, 2018. Join HRPO leadership to hear an overview of the changes and the types of research they may affect. This will be an informational session intending to deliver a broad stroke on the changes with upcoming sessions focusing on HRPO policies, implementation and the practical considerations of the changes.